Postpartum Thyroid Measures and Mood

Women with abnormal serum thyroid antibody levels or abnormal TSH and/or T4 values are more likely than their normal counterparts to have higher scores on a common postpartum depression screening test...

Date First Received: November 27, 2007

Last Updated: January 22, 2008

Verified by: Oklahoma State University Center for Health Sciences, January 2008

Clinical Trial Phase: N/A | Start Date: January 2000

Overall Status: Completed

Estimated Enrollment: 75

Brief Summary

Official Title: “Postpartum Thyroid Measures and Mood”

Condition Keyword(s):

Women with abnormal serum thyroid antibody levels or abnormal TSH and/or T4 values are more likely than their normal counterparts to have higher scores on a common postpartum depression screening test.

Study Type: Observational

Study Design: Cohort, Prospective

Detailed Clinical Trial Description

This small pilot study was an attempt to corroborate a relationship between quantified mood and thyroid measures, using the numerical scores obtained from a common depression screen, the Edinburgh Postnatal Depression Scale (EPDS), as a continuum. Mood scores were compared with presence of thyroid autoantibodies and plasma concentrations of free T4 and TSH.

Outcome Measures for this Clinical Trial

Primary Measures

  • Numerical score on the Edinburgh Postnatal Depression Scale
    • Time Frame: seven weeks

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Over 18 years of age
  • In third trimester of pregnancy when recruited
  • Negative for the following drugs detected by a urine drug screen:
  • Amphetamines
  • Barbiturates
  • Benzodiazepines
  • Cocaine
  • Opiates
  • Phencyclidine metabolites (PCP), and tricyclic antidepressants
  • Vaginal delivery
  • Screened negative for major depressive disorder on the Edinburgh Postnatal
  • Depression Scale (EPDS) at her prenatal enrollment in the study
  • Receiving a score of 12 or lower out of a possible 30

Exclusion Criteria:

  • Under age 18
  • Positive for any of the following drugs:
  • Amphetamines
  • Barbiturates
  • Benzodiazepines
  • Cocaine
  • Opiates
  • Phencyclidine metabolites (PCP), and tricyclic antidepressants
  • Cesarean delivery
  • EPDS score over 12 at prenatal screening test

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Sponsor Information

Lead Sponsor: Oklahoma State University Center for Health Sciences

Overall Clinical Trial Officials and Contacts

Gary H. Watson, PhD Study Director Philadelphia College of Osteopathic Medicine Georgia Campus  

Additional Information

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00565032

Study ID Number: 9899015

ClinicalTrials.gov Identifier: NCT00565032

Health Authority: United States: Institutional Review Board

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